FDA 483 - Clinical Formula LLC - December 03, 2021

Clinical Formula LLC, a drug manufacturer in Newport Beach, CA, was cited for significant deficiencies across its quality system, laboratory controls, stability testing, manufacturing processes, and materials management. The inspection revealed a lack of a functional quality control unit, scientifically unsound laboratory practices, unvalidated manufacturing processes, and inadequate supplier qualification, indicating a systemic failure to adhere to good manufacturing practices.